WO2022062779A1 - 一种经椎弓根椎间融合系统 - Google Patents

一种经椎弓根椎间融合系统 Download PDF

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Publication number
WO2022062779A1
WO2022062779A1 PCT/CN2021/113359 CN2021113359W WO2022062779A1 WO 2022062779 A1 WO2022062779 A1 WO 2022062779A1 CN 2021113359 W CN2021113359 W CN 2021113359W WO 2022062779 A1 WO2022062779 A1 WO 2022062779A1
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Prior art keywords
tube
assembly
outer tube
transpedicular
balloon
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PCT/CN2021/113359
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English (en)
French (fr)
Inventor
杨铭业
张鹏云
胡冬
刘载淳
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宁波华科润生物科技有限公司
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Publication of WO2022062779A1 publication Critical patent/WO2022062779A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires

Definitions

  • the invention relates to the technical field of medical devices, in particular to a transpedicular intervertebral fusion system.
  • Osteoporotic vertebral compression fractures are a common disease that endangers the health of middle-aged and elderly people.
  • the current surgical treatment methods include percutaneous vertebroplasty (PVP), implantation of a balloon to expand the vertebral body Protrusion plasty (PKP).
  • PVP percutaneous vertebroplasty
  • PGP Protrusion plasty
  • Implantable balloon kyphoplasty utilizes percutaneous puncture to insert an inflatable implantable balloon into a collapsed vertebral body.
  • the expansion of the implanted balloon elevates the endplate and restores the height of the vertebral body.
  • a cavity is formed in the vertebral body, the implantation balloon is withdrawn, and bone cement is finally injected.
  • the operation process is cumbersome, the patient is traumatized, the chance of complications is high, and the economic burden of the patient is also increased.
  • all operations need to be operated under X-ray monitoring. The more cumbersome and time-consuming the operation, the greater the damage to the doctor's health and the higher the physical requirements.
  • PVP percutaneous vertebroplasty
  • PGP implanted balloon kyphoplasty
  • intervertebral cage for treatment.
  • the principle of the intervertebral cage is to take the diseased intervertebral space as the center.
  • the anterior and posterior longitudinal ligaments are under continuous tension, so that the fusion segment and the cage can achieve three-dimensional hyperstatic fixation.
  • the vertebral body cage usually needs to scrape the fibrous tissue of the target intervertebral space before implanting the vertebral body cage, which destroys the physiological structure of the human body.
  • the entry channel is also larger, which causes greater damage to the patient, and it takes a long time to achieve fusion effect after surgery, and it is difficult to achieve satisfactory fusion effect for the elderly with poor bone quality.
  • Osteoporotic vertebral compression fractures, spinal degenerative diseases and structural damage are all common diseases that endanger the health of middle-aged and elderly people.
  • the elderly suffering from the two diseases especially the patients with multiple vertebral body lesions, they usually have to undergo multiple operations of different types, which are traumatized, the overall treatment cycle is long, and the operation cost is high.
  • transpedicular interbody fusion system which can not only solve the two diseases of osteoporotic vertebral body compression fracture and spinal degenerative disease and its structural damage for patients with multi-vertebral disease at the same time , reduce the number of operations in the entire treatment process of patients, shorten the operation time, and preserve the human physiological structure in the intervertebral space to a greater extent.
  • the purpose of the present invention is to provide a transpedicular interbody fusion system aiming at the deficiencies in the prior art.
  • the invention provides a transpedicular intervertebral fusion system, comprising a cavity opening assembly, an implanted balloon assembly, a delivery inner tube assembly and an outer tube assembly;
  • the cavity opening assembly includes a puncture needle tube assembly and a soft drill assembly;
  • the puncture needle tube assembly includes a connection port and a needle tube;
  • the soft drill assembly includes a flexible shaft and a drill bit;
  • the puncture needle tube assembly is connected to the soft drill assembly head through the connection port end connection;
  • the implanted balloon assembly includes an implanted balloon, an implanted balloon handle and a guide wire; the implanted balloon is in the shape of a dumbbell, and the distal end of the implanted balloon is also fixedly provided with a sealing head closed at the distal end; the sealing head The proximal end is provided with a blind hole with an opening facing the inside of the implantation balloon; the implantation balloon handle is connected with the proximal end of the implantation balloon;
  • the conveying inner tube assembly includes a conveying inner tube, a slider guide rail, an inner tube knob, an inner tube slider and a conveying port; the conveying inner tube is fixedly connected with the inner tube slider; the inner tube slider is connected to the inner tube slider.
  • the inner tube knob is threadedly connected, and the axial expansion and contraction of the conveying inner tube can be controlled by rotating the inner tube knob;
  • the outer tube assembly includes an outer tube, an outer tube slider and an outer tube knob; the outer tube is fixedly connected to the outer tube slider; the outer tube slider is threadedly connected to the outer tube knob, and is rotated by rotating the outer tube.
  • the outer tube knob can control the axial expansion and contraction of the outer tube;
  • the distal end of the curved section of the guide wire passes through the interior of the implantation balloon and is inserted into the blind hole;
  • the inner diameter of the outer tube is slightly larger than the outer diameter of the inner delivery tube, and the delivery
  • the inner tube is a rigid tube, the distal end of which is connected to the implantation balloon and can be slidably inserted into the outer tube; the distal end of the delivery inner tube or the distal end of the outer tube is deformed, so that the delivery The distal end of the inner tube and the distal end of the outer tube form a line or surface contact when assembled coaxially, so as to fix the proximal end of the implanted balloon between the delivery inner tube and the outer tube .
  • connection port is provided with threads, and the puncture needle tube assembly is threadedly connected to the head end of the soft drill assembly through the connection port.
  • the material of the flexible shaft is a shape memory alloy, and the bending angle is 80-100°; the drill bit is in the shape of a pointed tip, a round tip or a triangular pyramid, and has a rigidity that can withstand the thrust of tissue opening.
  • the shape memory alloy is a nickel-titanium alloy.
  • the implanted balloon is made of medical polymer material, and the upper and lower ends of the dumbbell-shaped balloon are also provided with micropores.
  • the implanted balloon is sintered PTFE membrane or woven with PET silk.
  • the conveying inner tube is glued, hot-melted or integrally injection-molded with the inner tube slider; the outer tube is glued, hot-melted or integrally injection-molded with the outer tube slide.
  • the delivery port is a standard luer connector for connecting a bone filler injection device.
  • the deformation treatment of the distal end of the inner delivery tube or the distal end of the outer tube is the flaring of the inner delivery tube or the narrowing of the outer tube.
  • the pressing rod assembly includes a pressing rod and a pressing rod handle.
  • the present invention adopts the above technical scheme, compared with the prior art, has the following technical effects:
  • the transpedicular intervertebral fusion system of the present invention completes the shaping of the upper and lower vertebral bodies through one puncture, and provides support for maintaining the height of the intervertebral space between the upper and lower vertebral bodies, which solves the problem in the prior art.
  • the existing problems have caused the patients suffering from the two diseases, especially the patients with multivertebral body lesions, to suffer less trauma, shorten the overall treatment time, and reduce the operation cost during the treatment process; a transvertebral body of the present invention
  • the arch root intervertebral fusion system only pushes away the physiological tissue in the intervertebral space when the cavity is opened, and most of the physiological structure between the vertebral bodies is preserved;
  • the present invention designs the fixed angle part of the distal end of the outer tube to be pre-installed In the adjustment tube, the instrument is made to pass through the working channel straightly, so that the operator does not have to put the instrument into the working channel effortlessly.
  • FIG. 1a is a schematic diagram of the assembly structure of the cavity assembly according to Embodiment 1 of the present invention.
  • FIG. 1b is a schematic view of the assembly cross-sectional structure of the cavity assembly according to Embodiment 1 of the present invention.
  • FIG. 2 is a schematic cross-sectional structural diagram of the puncture needle tube assembly according to Embodiment 1 of the present invention
  • FIG. 3a is a schematic diagram of the assembly structure of the implanted balloon assembly according to Embodiment 1 of the present invention.
  • 3b is a schematic cross-sectional structural diagram of the head end of the implanted balloon assembly according to Embodiment 1 of the present invention.
  • 3c is a schematic structural diagram of the implanted balloon according to Embodiment 1 of the present invention.
  • FIG. 4a is a schematic diagram of the assembly structure of the inner delivery tube assembly according to Embodiment 1 of the present invention.
  • FIG. 4b is a schematic cross-sectional structural diagram of the inner delivery tube assembly according to Embodiment 1 of the present invention.
  • FIG. 5 is a schematic diagram of the assembly structure of the outer tube assembly according to Embodiment 1 of the present invention.
  • FIG. 6 is a schematic diagram of a partial assembly structure of Embodiment 1 of the present invention.
  • Fig. 7a is a schematic diagram of an implanted balloon fixation method according to Embodiment 1 of the present invention.
  • FIG. 7b is a schematic diagram of another implantation balloon fixation method according to Embodiment 1 of the present invention.
  • Fig. 8a is a schematic diagram of the sagittal plane of the first stage use of Embodiment 2 or Embodiment 3 of the present invention.
  • Figure 8b is a schematic cross-section of the second-stage use of Embodiment 2 or Embodiment 3 of the present invention.
  • FIG. 9a is a schematic diagram of the use of the third stage of Embodiment 3 of the present invention.
  • FIG. 9b is a schematic diagram of the use of the third stage of Embodiment 3 of the present invention.
  • 10a is a schematic diagram of the use of the third stage of Embodiment 2 or the fourth stage of Embodiment 3 of the present invention.
  • 10b is a schematic diagram of the use of the fourth stage of Embodiment 2 or the fifth stage of Embodiment 3 of the present invention.
  • 10c is a schematic diagram of the use of the fourth stage of Embodiment 2 or the fifth stage of Embodiment 3 of the present invention.
  • 10d is a schematic diagram of the use of the fifth stage of Embodiment 2 or the sixth stage of Embodiment 3 of the present invention.
  • FIG. 10e is a schematic diagram of the use of the sixth stage of Embodiment 2 or the seventh stage of Embodiment 3 of the present invention.
  • 10f is a schematic diagram of the use of the sixth stage of Embodiment 2 or the eighth stage of Embodiment 3 of the present invention.
  • 10g is a schematic diagram of the use of the seventh stage of Embodiment 2 or the ninth stage of Embodiment 3 of the present invention.
  • Puncture needle assembly 10 connecting port 101; needle 102; soft drill assembly 20; flexible shaft 201; drill bit 202; implantation balloon assembly 30; implantation balloon 301; implantation balloon handle 302; guide wire 303; 304; Blind hole 305; Conveying inner tube assembly 40; Conveying inner tube 401; Slider guide rail 402; Inner tube knob 403; Inner tube slider 404; 502; outer tube knob 503; pedicle 601; upper vertebral body 602; intervertebral space 603; lower vertebral body 604; expansion implantation balloon 701; contrast agent injection port 702; expansion implantation balloon pressure pump connection port 703; pressing rod 801; pressing rod handle 802.
  • this embodiment provides a transpedicular interbody fusion system, including a cavity opening assembly, an implanted balloon assembly 30, a delivery inner tube assembly 40, an outer tube assembly 50, and a pressing rod assembly;
  • the cavity opening assembly includes a puncture needle tube assembly 10 and a soft drill assembly 20;
  • the puncture needle tube assembly 10 includes a connection port 101 and a needle tube 102;
  • the soft drill assembly 20 includes a flexible shaft 201 and a drill bit 202;
  • the connection port 101 is provided with Thread, the puncture needle tube assembly 10 is threadedly connected to the head end of the soft drill assembly 20 through the connection port 101;
  • the flexible shaft 201 is made of a shape memory alloy (preferably nickel-titanium alloy), and the bending angle is 80-100°;
  • the drill bit 202 is in the shape of a pointed tip, a round tip or a triangular pyramid, and has a rigidity that can withstand the thrust force of tissue opening;
  • the implantation balloon assembly 30 includes an implantation balloon 301, an implantation balloon handle 302 and a guide wire 303; the implantation balloon 301 is made of medical polymer material (preferably sintered PTFE membrane or PET wire). Weaving), in the shape of a dumbbell, with micro-holes provided at the upper and lower ends; the distal end of the implantation balloon 301 is fixedly provided with a sealing head 304 closed at the distal end; the proximal end of the sealing head 304 is provided with an opening facing the implantation The blind hole 305 inside the balloon 301 ; the implantation balloon handle 302 is connected with the proximal end of the implantation balloon 301 .
  • the conveying inner tube assembly 40 includes a conveying inner tube 401, a slider guide rail 402, an inner tube knob 403, an inner tube slider 404 and a conveying port 405; the conveying inner tube 401 is fixedly connected with the inner tube slider 404 ( The inner tube slider 404 is threadedly connected with the inner tube knob 403, and the inner tube knob 403 can be rotated to control the axial expansion and contraction of the conveying inner tube 401; so
  • the delivery port 405 is a standard luer connector for connecting the bone filler injection device;
  • the outer tube assembly 50 includes an outer tube 501, an outer tube slider 502 and an outer tube knob 503; the outer tube 501 is fixedly connected to the outer tube slider 502 (preferably by gluing, hot melting or integral injection molding); The outer tube slider 502 is threadedly connected with the outer tube knob 503, and the outer tube 501 can be controlled to expand and contract axially by rotating the outer tube knob 503;
  • the pressing rod assembly includes a pressing rod 801 and a pressing rod handle 802;
  • the distal end of the curved section of the guide wire 303 passes through the interior of the implantation balloon 301 and is inserted into the blind hole 305 ; the inner diameter of the outer tube 501 is slightly larger than the outer diameter of the inner delivery tube 401 .
  • the inner delivery tube 401 is a rigid tube, the distal end of which is connected to the implantation balloon 301 and can be slidably inserted into the outer tube 501; the distal end of the inner delivery tube 401 or the outer tube 501
  • the distal end of the inner tube is deformed (that is, the inner delivery tube 401 is flared or the outer tube 501 is closed), so that the distal end of the inner delivery tube 401 and the distal end of the outer tube 501 are assembled coaxially. Line or surface contact, so as to fix the proximal end of the implantation balloon 301 between the delivery inner tube 401 and the outer tube 501 .
  • S1 locate the diseased vertebra with the aid of X-ray C-arm or CT image, use the cavity opening component to percutaneously puncture the pedicle 601 into the upper vertebral body 602, and establish the first vertebra. a working channel;
  • S5 insert the pressing rod 801 along the delivery port 405, press the pressing rod handle 802 to make the bone cement completely enter the implantation balloon 301, and withdraw the pressing rod 801 and the pressing rod handle 802;
  • S6 rotate the outer tube knob 503 counterclockwise, so that the outer tube 501 is separated from the implantation balloon 301;
  • the puncture needle assembly 10 is pulled out, and the implantation balloon 301 is indwelled between the vertebral bodies to complete the operation.
  • S1 locate the diseased vertebra with the aid of X-ray C-arm or CT image, use the cavity opening component to percutaneously puncture the pedicle 601 into the upper vertebral body 602, and establish the first vertebra. a working channel;
  • S6 insert the pressing rod 801 along the delivery port 405, press the pressing rod handle 802 to make the bone cement completely enter the implantation balloon 301, and withdraw the pressing rod 801 and the bar handle 802.
  • the puncture needle assembly 10 is pulled out, and the implantation balloon 301 is indwelled between the vertebral bodies to complete the operation.

Abstract

一种经椎弓根椎间融合系统，包括开腔组件、植入球囊组件（30）、输送内管组件（40）和外管组件（50）；经椎弓根椎间融合系统通过一次穿刺，完成了上下两个椎体的成形，并为上下两椎体之间的椎间隙（603）的高度维持提供支撑，解决了现有技术中存在的问题，起到了使得罹患两种病症的患者特别是其中多椎体病变的患者在治疗过程中，受到的创伤小，整体治疗时间缩短，手术成本降低；经椎弓根椎间融合系统在进行开腔时，仅仅只是将椎间隙（603）中的生理组织推开，保留了绝大部分椎体间本身的生理结构。

Description

一种经椎弓根椎间融合系统 技术领域
本发明涉及医疗器械技术领域，尤其涉及一种经椎弓根椎间融合系统。
背景技术
骨质疏松性椎体压缩性骨折是危害中老年人健康的常见病，对于椎体压缩性骨折，目前的手术治疗方法有经皮椎体成形术(PVP)、植入球囊扩张椎体后凸成形术(PKP)。
植入球囊扩张椎体后凸成形术(PKP)利用经皮穿刺将一种可膨胀植入球囊置入塌陷的椎体，通过植入球囊的扩张抬升终板，回复椎体的高度，矫正后凸畸形，并在椎体内形成一个空腔，在较低压力下灌注高粘滞的骨水泥。为了使植入球囊顺利的进入椎体，需要先用穿刺针和工作套管建立工作通道，然后再使用骨钻钻出植入球囊在扩张前的工作通道，再将植入球囊送入椎体内，在椎体内形成一个空腔后撤出植入球囊，最后注入骨水泥。针对多节椎体病变的患者，手术中需要对每节椎体进行双侧穿刺注射骨水泥，手术过程繁琐，对患者创伤大、并发症发生机会高，也增加了患者的经济负担。并且，手术都需要在X光监控下操作，手术过程越繁琐时间越长对医生的健康损坏越大、体力要求越高。
此外，多椎体病变的患者往往还伴随着脊柱退行性疾病及其结构受损，现有的经皮椎体成形术(PVP)、植入球囊扩张椎体后凸成形术(PKP)只能起到单节椎体成形加固的手术效果，对于恢复脊柱前、中柱的应力及稳定，恢复、维持脊柱固有生理凸起，扩大椎间隙，缓解硬膜囊、神经根的受压的问题没有产生实际作用。
目前，患者通常还需要再使用椎间融合器进行治疗，椎间融合器的原理是以病变椎间隙为中心，在植入椎间融合器后，撑开力使融合节段的肌肉、纤维环和前、后纵韧带处于持续张力状态下，使融合节段和融合器达到三维超静力学固定。椎体融合器通常需要在植入椎体融合器前，刮除目标椎间隙的纤维组织，破坏了人体的生理结构，并且为了达到良好的支撑效果，设计时支撑面需尽量大，从而 导致植入通道也较大，对病人损伤较大，术后达到融合效果的时间较长，且对于骨质较差的老年人难以达到满意的融合效果。
骨质疏松性椎体压缩性骨折和脊柱退行性疾病及其结构受损都是目前危害中老年人健康的常见病。目前，国内外尚没有任何没有没有一个产品能够同时解决这两个中老年多发病症。对于罹患两种病症的老年人来讲，特别是其中多椎体病变的患者，通常要接受不同类型的多次手术，受到的创伤大，整体治疗周期长，手术成本高。
因此，亟需一种经椎弓根椎间融合系统，针对多椎体病变的患者，不仅能够同时解决骨质疏松性椎体压缩性骨折和脊柱退行性疾病及其结构受损这两个病症，减少患者整个治疗过程中的手术次数，缩短了手术时间，能够更大程度上保留椎间隙中的人体生理结构。
发明内容
本发明的目的是针对现有技术中的不足，提供一种经椎弓根椎间融合系统。
为实现上述目的，本发明采取的技术方案是：
本发明提供一种经椎弓根椎间融合系统，包括开腔组件、植入球囊组件、输送内管组件和外管组件；
所述开腔组件包括穿刺针管组件和软钻组件；所述穿刺针管组件包括连接口和针管；所述软钻组件包括软轴和钻头；所述穿刺针管组件通过连接口与所述软钻组件头端连接；
所述植入球囊组件包括植入球囊、植入球囊手柄和导丝；所述植入球囊呈哑铃型，其远端还固定设置有远端封闭的封头；所述封头近端设置有开口朝向所述植入球囊内部的盲孔；所述植入球囊手柄与所述植入球囊近端连接；
所述输送内管组件包括输送内管、滑块导轨、内管旋钮、内管滑块和输送口；所述输送内管与所述内管滑块固定连接；所述内管滑块与所述内管旋钮螺纹连接，通过旋转所述内管旋钮可控制所述输送内管轴向伸缩；
所述外管组件包括外管、外管滑块和外管旋钮；所述外管与所述外管滑块固定连接；所述外管滑块与所述外管旋钮螺纹连接，通过旋转所述外管旋钮可控制所述外管轴向伸缩；
其中，所述导丝弯曲段的远端穿过所述植入球囊的内部并插入于所述盲孔内；所述外管的内径略大于所述输送内管的外径，所述输送内管为刚性管，其远端连接所述植入球囊并可滑动插入于所述外管内；所述输送内管的远端或所述外管的远端经过变形处理，使得所述输送内管的远端和所述外管的远端同轴心装配时形成线或面的接触，从而将所述植入球囊的近端固定于所述输送内管和所述外管之间。
优选地，所述连接口设有螺纹，所述穿刺针管组件通过连接口与所述软钻组件头端螺纹连接。
优选地，所述软轴材质为形状记忆合金，弯曲角度为80-100°；所述钻头为尖头、圆头或三棱锥形状，具有承受组织开腔推力而不变性的刚度。
进一步优选地，所述形状记忆合金为镍钛合金。
优选地，所述植入球囊由医用高分子材料制成，其哑铃型的上下两端还设置有微孔。
进一步优选地，所述植入球囊为PTFE膜烧结定型或PET丝编织。
优选地，所述输送内管与所述内管滑块胶接、热熔或一体注塑；所述外管与所述外管滑块胶接、热熔或一体注塑。
优选地，所述输送口为用于连接骨填充物注射装置的标准鲁尔接头。
优选地，所述输送内管远端或所述外管远端的所述变形处理为所述输送内管扩口或所述外管收口。
优选地，还包括：压棒组件；所述压棒组件包括压棒和压棒手柄。
本发明采用以上技术方案，与现有技术相比，具有如下技术效果：
本发明的一种经椎弓根椎间融合系统通过一次穿刺，完成了上下两个椎体的成形，并为上下两椎体之间的椎间隙的高度维持提供支撑，解决了现有技术中存在的问题，起到了使得罹患两种所述病症的患者特别是其中多椎体病变的患者在治疗过程中，受到的创伤小，整体治疗时间缩短，手术成本降低；本发明的一种经椎弓根椎间融合系统在进行开腔时，仅仅只是将椎间隙中的生理组织推开，保留了绝大部分椎体间本身的生理结构；本发明设计外管远端的固定弯角部分预装在调节管内，使器械平直的通过工作通道，使操作者不用费力的把器械放入工作通道，通过操作调节管手柄实现外管远端的固定弯角部分的释放和回收。
附图说明
图1a为本发明实施例1的开腔组件装配结构示意图；
图1b为本发明实施例1的开腔组件装配剖面结构示意图；
图2为本发明实施例1的穿刺针管组件剖面结构示意图；
图3a为本发明实施例1的植入球囊组件装配结构示意图；
图3b为本发明实施例1的植入球囊组件头端剖面结构示意图；
图3c为本发明实施例1的植入球囊结构示意图；
图4a为本发明实施例1的输送内管组件装配结构示意图；
图4b为本发明实施例1的输送内管组件剖面结构示意图；
图5为本发明实施例1的外管组件装配结构示意图；
图6为本发明实施例1的部分装配结构示意图；
图7a为本发明实施例1的一种植入球囊固定方式示意图；
图7b为本发明实施例1的另一种植入球囊固定方式示意图；
图8a为本发明实施例2或实施例3的第一阶段使用示意图矢状面；
图8b为本发明实施例2或实施例3的第二阶段使用示意图横断面；
图9a为本发明实施例3的第三阶段使用示意图；
图9b为本发明实施例3的第三阶段使用示意图；
图10a为本发明实施例2的第三阶段或实施例3的第四阶段使用示意图；
图10b为本发明实施例2的第四阶段或实施例3的第五阶段使用示意图；
图10c为本发明实施例2的第四阶段或实施例3的第五阶段使用示意图；
图10d为本发明实施例2的第五阶段或实施例3的第六阶段使用示意图；
图10e为本发明实施例2的第六阶段或实施例3的第七阶段使用示意图；
图10f为本发明实施例2的第六阶段或实施例3的第八阶段使用示意图；
图10g为本发明实施例2的第七阶段或实施例3的第九阶段使用示意图；
其中的附图标记为：
穿刺针管组件10；连接口101；针管102；软钻组件20；软轴201；钻头202；植入球囊组件30；植入球囊301；植入球囊手柄302；导丝303；封头304；盲孔305；输送内管组件40；输送内管401；滑块导轨402；内管旋钮403；内管 滑块404；输送口405；外管组件50；外管501；外管滑块502；外管旋钮503；椎弓根601；上节椎体602；椎间隙603；下节椎体604；扩张植入球囊701；造影剂注入口702；扩张植入球囊压力泵连接口703；压棒801；压棒手柄802。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动的前提下所获得的所有其他实施例，都属于本发明保护的范围。
需要说明的是，在不冲突的情况下，本发明中的实施例及实施例中的特征可以相互组合。
下面结合附图和具体实施例对本发明作进一步说明，但不作为本发明的限定。
实施例1
如图1-7所示，本实施例提供一种经椎弓根椎间融合系统，包括开腔组件、植入球囊组件30、输送内管组件40、外管组件50和压棒组件；
所述开腔组件包括穿刺针管组件10和软钻组件20；所述穿刺针管组件10包括连接口101和针管102；所述软钻组件20包括软轴201和钻头202；所述连接口101设有螺纹，所述穿刺针管组件10通过连接口101与所述软钻组件20头端螺纹连接；所述软轴201材质为形状记忆合金(优选为镍钛合金)，弯曲角度为80-100°；所述钻头202为尖头、圆头或三棱锥形状，具有承受组织开腔推力而不变性的刚度；
所述植入球囊组件30包括植入球囊301、植入球囊手柄302和导丝303；所述植入球囊301由医用高分子材料制成(优选为PTFE膜烧结定型或PET丝编织)，呈哑铃型，上下两端设置有微孔；所述植入球囊301远端固定设置有远端封闭的封头304；所述封头304近端设置有开口朝向所述植入球囊301内部的盲孔305；所述植入球囊手柄302与所述植入球囊301近端连接。
所述输送内管组件40包括输送内管401、滑块导轨402、内管旋钮403、内管滑块404和输送口405；所述输送内管401与所述内管滑块404固定连接(优 选为胶接、热熔或一体注塑)；所述内管滑块404与所述内管旋钮403螺纹连接，通过旋转所述内管旋钮403可控制所述输送内管401轴向伸缩；所述输送口405为用于连接骨填充物注射装置的标准鲁尔接头；
所述外管组件50包括外管501、外管滑块502和外管旋钮503；所述外管501与所述外管滑块502固定连接(优选为胶接、热熔或一体注塑)；所述外管滑块502与所述外管旋钮503螺纹连接，通过旋转所述外管旋钮503可控制所述外管501轴向伸缩；
所述压棒组件包括压棒801和压棒手柄802；
其中，所述导丝303弯曲段的远端穿过所述植入球囊301的内部并插入于所述盲孔305内；所述外管501的内径略大于所述输送内管401的外径，所述输送内管401为刚性管，其远端连接所述植入球囊301并可滑动插入于所述外管501内；所述输送内管401的远端或所述外管501的远端经过变形处理(即所述输送内管401扩口或所述外管501收口)，使得所述输送内管401的远端和所述外管501的远端同轴心装配时形成线或面的接触，从而将所述植入球囊301的近端固定于所述输送内管401和所述外管501之间。
实施例2
如图8a所示，S1、在X射线C型臂或CT影像辅助下定位病椎，使用所述开腔组件经皮再经椎弓根601穿刺入路，进入上节椎体602中，建立第一工作通道；
如图8b所示，S2、旋转并同时推进所述软钻组件20，在所述上节椎体602、椎间隙603与下节椎体604间建立80°-100°的第二弯曲通道；
如图10a所示，S3、拔出所述软钻组件20并插入所述植入球囊组件30、所述输送内管组件40和所述外管组件50，至所述封头304达到第二弯曲通道底端，并拔出所述导丝手柄302；
如图10b和图10c所示，S4、沿所述输送口405注射骨水泥，注射量匹配所述植入球囊301的膨胀体积，并逆时针旋转所述输送内管旋钮403，回缩所述输送内管401，使所述输送内管401近端脱离所述植入球囊301；
如图10d所示，S5、沿所述输送口405插入所述压棒801，压紧所述压棒手柄802使骨水泥完全进入所述植入球囊301中，并抽回所述压棒801与所述压棒 手柄802；
如图10e和图10f所示，S6、逆时针转动所述外管旋钮503，使所述外管501脱离所述植入球囊301；
如图10g所示，S7、抽出所述穿刺针管组件10，将所述植入球囊301留置于椎体间，完成手术。
实施例3
如图8a所示，S1、在X射线C型臂或CT影像辅助下定位病椎，使用所述开腔组件经皮再经椎弓根601穿刺入路，进入上节椎体602中，建立第一工作通道；
如图8b所示，S2、旋转并同时推进所述软钻组件20，在所述上节椎体602、椎间隙603与下节椎体604间建立80°-100°的第二弯曲通道；
如图9a和图9b所示，S3、插入扩张球囊组件，使扩张植入球囊701达到所述下节椎体604的第二弯曲通道底端，沿造影剂注入口702注入造影剂，在X射线C型臂辅助下确认所述扩张植入球囊701位置，在扩张植入球囊压力泵连接口703连接压力泵，扩张椎体内松质骨；再使用同样方法扩张所述上节椎体602内松质骨；
如图10a所示，S4、拔出所述软钻组件20并插入所述植入球囊组件30、所述输送内管组件40与所述外管组件50，至所述封头304达到第二弯曲通道底端，并拔出所述导丝手柄302；
如图10b和图10c所示，S5、沿所述输送口405注射骨水泥，注射量匹配所述植入球囊301的膨胀体积，并逆时针旋转所述输送内管旋钮403，回缩所述输送内管401，使所述输送内管401近端脱离所述植入球囊301；
如图10d所示，S6、沿所述输送口405插入所述压棒801，压紧所述压棒手柄802使骨水泥完全进入所述植入球囊301中，并抽回所述压棒801与所述压棒手柄802。
如图10e和图10f所示，S7、逆时针转动所述外管旋钮503，使所述外管501脱离所述植入球囊301；
如图10g所示，S8、抽出所述穿刺针管组件10，将所述植入球囊301留置于椎体间，完成手术。
以上所述仅为本发明较佳的实施例，并非因此限制本发明的实施方式及保护范围，对于本领域技术人员而言，应当能够意识到凡运用本发明说明书及图示内容所作出的等同替换和显而易见的变化所得到的方案，均应当包含在本发明的保护范围内。

Claims (10)

  1. 一种经椎弓根椎间融合系统，其特征在于，包括开腔组件、植入球囊组件(30)、输送内管组件(40)和外管组件(50)；
    所述开腔组件包括穿刺针管组件(10)和软钻组件(20)；所述穿刺针管组件(10)包括连接口(101)和针管(102)；所述软钻组件(20)包括软轴(201)和钻头(202)；所述穿刺针管组件(10)通过连接口(101)与所述软钻组件(20)头端连接；
    所述植入球囊组件(30)包括植入球囊(301)、植入球囊手柄(302)和导丝(303)；所述植入球囊(301)呈哑铃型，其远端还固定设置有远端封闭的封头(304)；所述封头(304)近端设置有开口朝向所述植入球囊(301)内部的盲孔(305)；所述植入球囊手柄(302)与所述植入球囊(301)近端连接；
    所述输送内管组件(40)包括输送内管(401)、滑块导轨(402)、内管旋钮(403)、内管滑块(404)和输送口(405)；所述输送内管(401)与所述内管滑块(404)固定连接；所述内管滑块(404)与所述内管旋钮(403)螺纹连接，通过旋转所述内管旋钮(403)可控制所述输送内管(401)轴向伸缩；
    所述外管组件(50)包括外管(501)、外管滑块(502)和外管旋钮(503)；所述外管(501)与所述外管滑块(502)固定连接；所述外管滑块(502)与所述外管旋钮(503)螺纹连接，通过旋转所述外管旋钮(503)可控制所述外管(501)轴向伸缩；
    其中，所述导丝(303)弯曲段的远端穿过所述植入球囊(301)的内部并插入于所述盲孔(305)内；所述外管(501)的内径略大于所述输送内管(401)的外径，所述输送内管(401)为刚性管，其远端连接所述植入球囊(301)并可滑动插入于所述外管(501)内；所述输送内管(401)的远端或所述外管(501)的远端经过变形处理，使得所述输送内管(401)的远端和所述外管(501)的远端同轴心装配时形成线或面的接触，从而将所述植入球囊(301)的近端固定于所述输送内管(401)和所述外管(501)之间。
  2. 根据权利要求1所述的经椎弓根椎间融合系统，其特征在于，所述连接口(101)设有螺纹，所述穿刺针管组件(10)通过连接口(101)与所述软钻组件(20) 头端螺纹连接。
  3. 根据权利要求1所述的经椎弓根椎间融合系统，其特征在于，所述软轴(201)材质为形状记忆合金，弯曲角度为80-100°；所述钻头(202)为尖头、圆头或三棱锥形状，具有承受组织开腔推力而不变性的刚度。
  4. 根据权利要求3所述的经椎弓根椎间融合系统，其特征在于，所述形状记忆合金为镍钛合金。
  5. 根据权利要求1所述的经椎弓根椎间融合系统，其特征在于，所述植入球囊(301)由医用高分子材料制成，其哑铃型的上下两端还设置有微孔。
  6. 根据权利要求5所述的经椎弓根椎间融合系统，其特征在于，所述植入球囊(301)为PTFE膜烧结定型或PET丝编织。
  7. 根据权利要求1所述的经椎弓根椎间融合系统，其特征在于，所述输送内管(401)与所述内管滑块(404)胶接、热熔或一体注塑；所述外管(501)与所述外管滑块(502)胶接、热熔或一体注塑。
  8. 根据权利要求1所述的经椎弓根椎间融合系统，其特征在于，所述输送口(405)为用于连接骨填充物注射装置的标准鲁尔接头。
  9. 根据权利要求1所述的经椎弓根椎间融合系统，其特征在于，所述输送内管(401)远端或所述外管(501)远端的所述变形处理为所述输送内管(401)扩口或所述外管(501)收口。
  10. 根据权利要求1所述的经椎弓根椎间融合系统，其特征在于，还包括：压棒组件；所述压棒组件包括压棒(801)和压棒手柄(802)。
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